FDA grants fast track designation to dry AMD gene therapy
The FDA has granted fast track designation to GT005 for the treatment of geographic atrophy secondary to dry age-related macular degeneration, according to a press release from Gyroscope Therapeutics.
The designation is for patients with specific mutations in the complement factor I gene and low levels of CFI protein in their blood. Enrollment is underway in the EXPLORE phase 2 study to evaluate GT005 in these patients.
“Dry AMD is a life-altering diagnosis, and there are currently no FDA-approved medicines available. Research suggests people with dry AMD who have certain CFI mutations that correlate with low CFI levels in the blood have a higher risk of developing AMD,” Nadia Waheed, MD, MPH, chief medical officer of Gyroscope Therapeutics, said in the release.
The company plans to begin a phase 2 trial in a broader group of patients before the end of the year.